WO1999044167A1 - Systeme de gestion de medicaments de pharmacie procurant une posologie de medicaments specifique au patient, une analyse des interactions medicamenteuses, la generation de prescriptions et une adaptation des donnees du patient - Google Patents

Systeme de gestion de medicaments de pharmacie procurant une posologie de medicaments specifique au patient, une analyse des interactions medicamenteuses, la generation de prescriptions et une adaptation des donnees du patient Download PDF

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Publication number
WO1999044167A1
WO1999044167A1 PCT/US1999/003008 US9903008W WO9944167A1 WO 1999044167 A1 WO1999044167 A1 WO 1999044167A1 US 9903008 W US9903008 W US 9903008W WO 9944167 A1 WO9944167 A1 WO 9944167A1
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WIPO (PCT)
Prior art keywords
drug
patient
receiving
dosing
interaction
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PCT/US1999/003008
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English (en)
Inventor
Thomas L. Kapp
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Rx Communications, Inc.
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Publication date
Application filed by Rx Communications, Inc. filed Critical Rx Communications, Inc.
Priority to AU26735/99A priority Critical patent/AU2673599A/en
Publication of WO1999044167A1 publication Critical patent/WO1999044167A1/fr

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    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H70/00—ICT specially adapted for the handling or processing of medical references
    • G16H70/40—ICT specially adapted for the handling or processing of medical references relating to drugs, e.g. their side effects or intended usage
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records

Definitions

  • the present invention relates to a comprehensive pharmacy drug management system for preventing iatrogenic drug effects, and more particularly to a pharmacy drug management system providing a single pharmacy drug management software package for patient specific drug dosing, drug interaction analysis, order generation, and patient data matching.
  • Iatrogenic illnesses (illnesses caused by the medical profession) have been a significant cause of disease and death of patients. Most iatrogenic illnesses result from complications of drug therapy. Adverse drug reactions have been the cause of roughly 10% of all hospital admissions. Thirty six percent or more of hospitalized patients have their problems compounded by suffering iatrogenic drug effects. We could assume then that many ambulatory patients, especially those on numerous medications and suffering a variety of ailments, are also candidates for iatrogenic drug problems. Further, it is believed that iatrogenic drug illnesses cost the American economy many billions of dollars a year.
  • Preparing and processing an order begins with a doctor physically writing an order.
  • the order is then entered by a nurse into a computer connected to a pharmacy database so that the order may be processed. While the order is being processed, the doctor depending on the time of day is busy with other patients or has left the hospital.
  • the order may then come up on the screen of the computer indicating there is a drug interaction problem.
  • the ordered drug may have a problem interacting with another drug prescribed for the patient.
  • the ordered drug might also negatively impact the patient's medical condition.
  • Drug interaction information for certain drugs is stored in the pharmacy database.
  • a message pops up on the screen of the computer system indicating a drug interaction problem.
  • the doctor is then called or paged and requested to prepare a new order. Meanwhile, the patient who is in need of immediate drug therapy must wait for the doctor to write a new order. If the drug selected for the new order also causes a drug interaction problem detected by the computer system, then filling the order is again delayed.
  • the conventional system for preparing and processing an order thus not only creates an order without taking patient-specific data into account (particularly since an order is physically written) but also checks for drug interaction problems after an order has already been written.
  • Adverse drug reactions are particularly significant in geriatric pharmacology. Elderly persons often have multiple chronic diseases and are under multiple medications, increasing concern regarding drug-drug (or drug to drug) and drug-disease interactions. Many common symptoms of the elderly (e.g., gastrointestinal problems, dizziness, and mental status changes) can be difficult to distinguish from drug side effects or may be caused and exacerbated by medications. Introduction of a new medication into the regime of an elderly individual is thus fraught with adverse possibilities.
  • Overdosing and underdosing of drugs has also contributed to numerous iatrogenic illnesses.
  • precise therapeutic dosing levels must be determined.
  • the goal of the medical profession has been to avoid overdosing and underdosing by tailoring drug administration to an individual patient's needs.
  • the medical profession has predominately utilized pharmacokinetic principles in drug dosing.
  • the basic pharmacokinetic parameters which include volume of distribution, rate of metabolizing, rate of excretion, rate of absorption and half-life, are commonly used in equations for calculating dosing amounts and the dosing integral for drugs requiring precise therapeutic dosing levels.
  • the present invention provides a pharmacy drug management system for monitoring and correcting iatrogenic drug illnesses so as to deliver optimum drug therapy to a patient in a managed care environment.
  • the pharmacy drug management system provides patient specific drug dosing, drug interaction analysis, order generation, and patient data matching.
  • the modules provided by the pharmacy drug management software include a drug interaction analysis sub-module, a drug dosing module, an order generation module, and a patient data matching module. Through the drug interaction analysis sub-module, each drug to be prescribed will be examined for potential problems associated with other drugs and medical data of the patient such as the medical condition, allergy and food of the patient.
  • the module allows the input of detailed medical history, allergies, diet and prescribed drugs from all physicians being seen by the patient, drugs that are intended to be prescribed, and any non-prescription medications that are being used.
  • the module checks for drug to drug interactions and drug interactions based on the medical condition of the patient. In this way, the module will alert the physician and clinical pharmacist of the potential drug interaction problems before they occur.
  • the module also provides advisories concerning particular drugs and recommendations of alternate drugs to use in place of certain drugs.
  • the detection and correction of drug interaction problems by the drug interaction analysis sub-module serve to minimize clinical liability for adverse drug reactions.
  • Clinical liability for adverse drug reactions is further managed through tracking the adverse drug reaction efficiency for each doctor and pharmacist. This is the ultimate conceptual system of managed care practice of preventive medicine vis-a-vis prescribing.
  • the drug interaction analysis sub-module is contained in a therapy management module supporting a variety of features. These features include a note or internal chart for maintaining a continuous chain of events for a patient, an infusion calculator for computing an infusion rate for a drug, a worksheet for listing the current drugs of the patient, advisories for providing information specific to particular drugs and information specific to particular classes of patients,
  • the doctor or pharmacist thus is provided with an integrated interface for using numerous drug therapy tools simultaneously.
  • the drug dosing module determines precise therapeutic drug dosing levels for drugs having a narrow therapeutic index.
  • drugs for example, may include aminoglycosides, cephlosporins, antibiotics, cardiovascular disease drugs, and pulmonary disease drugs.
  • the module uses patient specific data and pharmacokinetic principles to properly dose the patient.
  • the module also provides dosing guidelines based on a programmed clinical judgment in response to particular modifying factors (factors influencing creatinine clearance) of the patient.
  • the module serves as a therapeutic monitor by predicting the levels of a drug within a patient and providing review of a therapeutic range for the patient.
  • the pharmacy drug management system becomes an online clinical consultant. Through the use of the drug interaction analysis sub-module and the drug dosing module, the patient's course of therapy is set.
  • the order generation module After the patient's course of therapy is set by the drug dosing module and the drug interaction analysis sub-module, using the order generation module, a doctor or pharmacist processes an on-screen order.
  • the on-screen order includes the standard components of a written order.
  • the screen provides a hospital formulary so that specific drugs provided by a drug manufacturer may be selected for entry into the order.
  • the order is printed out as a label that is affixed to a container for the drug and is also printed out as a prescription for the patient.
  • the order module also includes the capability to recreate an order for generation of a renewal order, to control drug inventory, and to reorder drugs when a drug reaches a predetermined amount.
  • the patient data matching module calls a patient data matching database external to the computer system to match the current patient's medical condition to previous patient therapies that have been administered for treatment of patients with similar medical conditions. Through the entry of specific data, the module will extract similar patient parameters meeting the criteria of the medical condition. The clinical professional can then review the matched patients, complete with the drug therapy administered for treatment and the clinical outcomes. The clinician can continue the course that has been set for the patient or alter the course of therapy based on the clinical data from the matches.
  • the patient data matching database is a relational database provided on a website.
  • FIG. 1 is a block diagram of drug management software in accordance with prior art invented by Applicant
  • Figure 2 is a schematic block diagram of the relationship between a drug to drug interaction module and associated data blocks of the drug management software of Figure 1 ;
  • Figure 3 is a flow chart of a drug dosing process performed by the drug management software of Figure 1;
  • Figure 4 is a schematic diagram of a pharmacy drug management system including pharmacy drug management software in accordance with the present invention
  • Figure 5 is a schematic block diagram of modules of the pharmacy drug management software of Figure 4;
  • Figure 6 is a schematic block diagram of the relationship between the drug interaction analysis sub-module of the THERAPY COORDINATOR module of Figure 5 and associated data blocks;
  • Figures 7A-7B are flow charts of a drug management process performed by the computer system of Figure 4 in executing the pharmacy drug management software of Figure 4;
  • Figures 8A-8B are flow charts of the THERAPY_COORDINATOR module of Figure 5 called by the drug management process of Figures 7A-7B;
  • FIGS 9A-9F are flow charts of the KINETIC_DRUG_DOSER module called by the drug management process of Figures 7A-7B;
  • Figure 10 is a flow chart of an ARCHIVE_DATAB ASE SYSTEM module called by the drug management process of Figures 7A-7B;
  • Figure 11 is an illustration of fields of an exemplary record for storing patient data in the patient data module matching database of Figure 4;
  • Figure 12 is a block diagram of features of the pharmacy drug management software of
  • Figure 13 is an illustration of an exemplary opening window displayed by the pharmacy drug management software of Figure 4.
  • Figure 14 is an illustration of an exemplary patient data window displayed by the pharmacy drug management software of Figure 4
  • Figure 15 is an illustration of an exemplary add medication window displayed by the pharmacy drug management software of Figure 4;
  • Figure 16 is an illustration of an exemplary drug interaction warning window displayed by the THERAPY_COORDINATOR module of Figure 5;
  • Figure 17 is an illustration of an exemplary contraindication warning window displayed by the THERAPY COORDINATOR module of Figure 5 ;
  • Figure 18 is an illustration of an exemplary Rx Worksheet window depicting a contraindications list by the THERAPY__COORDINATOR module of Figure 5;
  • Figure 19 is an illustration of an exemplary Rx Worksheet window depicting a medication list by the THERAPY_COORDINATOR module of Figure 5;
  • Figure 20 is an illustration of an exemplary add medical condition window displayed by the THERAPY_COORDINATOR module of Figure 5;
  • Figure 21 is an illustration of an exemplary medication advisory window displayed by the THERAPY__COORDINATOR module of Figure 5;
  • Figure 22 is an illustration of an exemplary doser drug indication window displayed by the THERAP Y_COORDIN ATOR module of Figure 5 ;
  • Figure 23 is an illustration of an exemplary modifying factors window displayed by the KINETIC_DRUG_DOSER module of Figures 9A-9F;
  • Figure 24 is an illustration of an exemplary malnutrition window displayed by the KINETIC_DRUG_DOSER module of Figures 9A-9F;
  • Figure 25 is an illustration of an exemplary calculated volume of distribution window displayed by the KINETIC_DRUG_DOSER module of Figures 9A-9F;
  • Figure 26 is an illustration of an exemplary infusion time window displayed by the KINETIC__DRUG_DOSER module of Figures 9A-9F;
  • Figure 27 is an illustration of an exemplary estimated dosage window displayed by the KINETIC_DRUG_DOSER module of Figures 9A-9F;
  • Figure 28 is an illustration of an exemplary selected dose calculation window displayed by the KINETIC_DRUG_DOSER module of Figures 9A-9F for prospective dosing;
  • Figure 29 is an illustration of an exemplary doser results window displayed by the KINETIC_DRUG_DOSER module of Figures 9A-9F for prospective dosing;
  • Figure 30 is an illustration of an exemplary infusion calculator window displayed by the
  • Figure 31 is an illustration of an exemplary infusion calculator results window displayed by the THERAPY_COORDINATOR module of Figure 5;
  • Figure 32 is an illustration of an exemplary note window displayed by the THERAP Y_COORDINATOR module of Figure 5 ;
  • Figure 33 is an illustration of an exemplary order window displayed by the ORDER_GENERATION_S YSTEM module called by the drug management process of Figure 7;
  • Figure 34 is an illustration of an exemplary improve dose infusion entry window displayed by the KINETIC_DRUG_DOSER module of Figures 9A-9B;
  • Figure 35 is an illustration of an exemplary selected improve dose window displayed by the KINETIC_DRUG_DOSER module of Figures 9A-9F;
  • Figure 36 is an illustration of an exemplary SDC plot window displayed by the
  • FIG. 1 is a block diagram of drug management software in accordance with prior art invented by Applicant.
  • the software package 10 includes a patient data entry module 12, a drug to drug interaction module 14, a prospective dosing module 16, an improved dosing module 18, an infusion calculator 20, a patient record review module 22, and a graph display module 24.
  • the patient data entry module 12 permits entry of patient data.
  • a user may initiate the drug to drug interaction module 14.
  • the module 14 checks for a drug to drug interaction problem.
  • the module 14 detects any adverse drug reaction resulting from a combination of a selected drug and a current drug of the patient. It should be understood that both the selected drug and current drug of the patient must be known by the drug management software.
  • a user may execute the prospective dosing module 16 for determining desired peak and trough blood levels for a patient.
  • the module 16 uses pharmacokinetic equations known in the art in calculating these blood
  • the user has the option of executing the improved dosing module 18 for computing a dosage to achieve serum drug concentration (SDC) optimization.
  • a user also has access at any time to the infusion calculator module 20 for computing an infusion rate for a particular drug.
  • a user further has the option of reviewing and writing the dosing information into a patient record using the patient record review module 22 and the further option of displaying an SDC graph using the graph display module 24.
  • This drug management software invented by Applicant and provided under the trademark THERAPY COORDINATORTM introduced drug management software for both therapeutic drug dosing and drug to drug interaction analysis. Referring to Figure 2, a schematic block diagram of the relationship between the drug to drug interaction module 30 and associated data blocks of the drug management software 10 is shown.
  • the drug to drug interaction module 30 uses a drug interaction file 32, a drug file 34, and a current drugs of patient file 28.
  • the drug file 34 includes a list of available drugs, and the drug interaction file 32 includes information concerning the adverse effects of particular drug combinations.
  • the drugs of interest in the prior art drug management software 10 were amikacin, ceftriaxone, digoxin, gentamicin, lidocaine, phenytoin, procainamide, theophylline, tobramycin, vancomycin, and warfarin.
  • the drug to drug interaction module 30 uses the current drugs of the patient and the new drug as a search criterion for locating information within the drug interaction file 32 relevant to the patient. Any records within the drug interaction file 32 which match that search criterion are provided to the drug to drug interaction module 30.
  • step 38 a flow chart of a drug dosing process performed by the prior art drug management software 10 invented by Applicant is shown.
  • the drug dosing process 36 begins at step 38 where patient data is entered. From step 38, control proceeds to step 40 where a particular drug for the patient is then entered. Control next proceeds to step 42 where the user may enter a most recent maintenance dose.
  • step 44 the process checks for a drug to drug interaction problem using the drug interaction file 32. In step 46, it is specifically determined if a drug interaction problem was detected. If a drug interaction problem was detected, control returns to step 40 where the user may enter a different drug. This process of detecting drug to drug interaction problems is performed by the drug to drug interaction module 30 (Fig. 2). If a drug to drug interaction problem is not detected, then control proceeds to step
  • step 48 a loading dose and maintenance dose are computed using pharmacokinetic
  • step 50 an improved dosage is computed to optimize serum drug concentration (SDC). This operation is performed within the improved dosing module 18 (Fig. 1). From step 50, control proceeds to step 52 where a user may display a serum drug concentration graph. Display of this graph occurs within the graph display module 24 (Fig. 1).
  • Control then proceeds to step 54 where patient data may be viewed and saved to a record. Drug dosing is completed in step 56.
  • FIG. 4 a schematic diagram of a pharmacy drug management system 90 including pharmacy drug management software 124 (Figs. 5 and 6) in accordance with the present invention is shown.
  • the pharmacy drug management software 124 of the present invention may be stored on a pharmacy drug management compact disc (CD) 114.
  • the computer system 100 includes a CD-ROM drive 104 for receiving the pharmacy drug management CD 114.
  • the processor 102 of the computer system 100 serves to execute the pharmacy drug management software 124 when the pharmacy drug management CD 114 is present within the CD-ROM drive 104.
  • the processor 102 may execute the pharmacy drug management software 124 from a memory 108 if the pharmacy drug management software 124 has been stored to that memory.
  • the computer system 100 further includes a modem 106 having a line for connecting to a drug company 116, a drug store 118, and a web site 120.
  • the pharmacy drug management software 124 may communicate with the drug company 116 for reordering drugs when a drug reaches a predetermined amount.
  • the software 124 may also electronically communicate an order for a patient directly to the drug store 188.
  • the web site 120 includes a patient data matching database 122.
  • the patient data matching database 122 may be accessed at any time by a patient data matching module 130 (Fig. 5) of the pharmacy drug management software 124.
  • the computer system 100 further includes a display screen 110 for communicating information to a pharmacist or doctor and a printer 112 for receiving reports generated by a report writer module 134 (Fig. 5) of the software 124.
  • a report writer module 134 Fig. 5
  • One type of report which may be generated and printed is a report, known as a DUE, indicating the utilization of a drug.
  • the report may also indicate the top drugs prescribed and which doctors are writing orders resulting in adverse drug reactions.
  • the computer system 100 may be of any type, such as desktop, laptop, or handheld, and may be for standalone or network use. It is contemplated that the pharmacy drug management system of the present invention may be used at any location in the world to control iatrogenic illnesses, such as a hospital, nursing home, HMO, or a home healthcare or home infusion business.
  • the pharmacy drug management software 124 includes a drug dosing module 126, a therapy management module 128 termed the THERAPY COORDINATOR, an order generation module 132, and the report writer module 134.
  • the THERAP Y_COORDINATOR module 128 provides a drug interaction analysis sub- module 150.
  • the drug interaction analysis sub-module 150 is used to detect and correct drug interaction problems. These drug interaction problems not only include drug to drug interaction problems, but also problems based on interactions between a drug and a medical condition, allergy, or diet of a patient.
  • the results obtained by the drug interaction analysis sub-module 128 may be provided to the report writer 134.
  • the drug interaction analysis sub-module 150 fetches medical data for the patient from a list of the patients' medical conditions.
  • the drug dosing module 126 is used for drugs having a narrow therapeutic index.
  • the module 126 provides both prospective and improved dosing of drugs within this category.
  • the drugs for which information is provided include aminoglycasides, strong antibiotics, cephlosporins, cardiovascular disease drugs, and pulmonary disease drugs, to name a few. These particular drugs require both careful dosing and continuous monitoring.
  • a drug dosed by the drug dosing module 126 may be entered into an order using the order generation module 132.
  • the order generation module 132 which is termed the ORDER_GENERATION_S YSTEM, provides an on-screen order to a doctor or pharmacist. By using the pharmacy drug management software
  • the drug interaction analysis sub-module 150 receives patient physical data 138, clinical lab reports 140, the current drugs of the patient 142, the medical condition of the patient 144, the patient internal chart 146, and the diet of the patient 148.
  • the drug interaction analysis sub-module 150 utilizes each of these forms of patient medical data in determining whether a drug interaction problem exists.
  • the drug interaction analysis sub-module 150 uses the patient medical data, drugs, and the new drug as a search criterion for searching a drug information file 154 and a medical condition file 152.
  • the drug information file 154 contains information concerning a drug-drug interaction or a drug-food interaction. It should be understood that a food or drug allergy of a patient may contribute to a drug-drug interaction or drug-food interaction.
  • the drug file 156 contains a list of the available drugs.
  • the drug management process performed by the THERAP Y__COORDINATOR module 128 begins at step 160 where a doctor or pharmacist ID is entered.
  • a patient ID is then entered.
  • Figure 13 depicts an exemplary window for such entry.
  • control proceeds to step 164 where patient data is then entered.
  • patient data includes a patient ID, a doctor ID, a location of the patient, a room number of the patient, a name of the patient, a date of birth, a height of the patient, and a weight of the patient as illustrated by the exemplary patient window in Figure 14.
  • step 164 the doctor or pharmacist may proceed to step 166, 168, 170 or 174.
  • step 166 the doctor or pharmacist is able to add a drug for the selected patient.
  • Figure 15 depicts an exemplary "add medication" window for such an entry.
  • step 168 the doctor or pharmacist is able to add a medical condition for the selected patient.
  • a medical condition may be selected by searching for a medical condition by the ICD-9 class number of the medical condition, the ICD-9 subclass number of the medical condition, or the name of the medical condition as illustrated by the "add medical condition" window of Figure 20.
  • ICD-9 codes and subcodes are used in the United States to identify medical diagnoses. From either step 166 or step 168, control proceeds to step 176 where the drug interaction analysis sub-module 150 is called.
  • step 184 the new drug selected for the patient is compared with the current drugs of the patient.
  • step 186 the new drug is then compared with the food included in the diet of the patient.
  • step 188 the new drug is compared with the medical conditions of the patient.
  • step 190 the new drug is compared with the allergies (food and drug) of the patient.
  • step 192 it is determined whether there is a drug interaction problem for the particular patient.
  • control proceeds to step 194 where an indication that a drug interaction problem is not present is provided. From step 194, control proceeds to step 204. If a drug interaction problem is detected, control proceeds to step 196 where a warning is provided. If the detected problem is an interaction between drugs, a "drug interaction" warning is provided. If the detected problem is an interaction between the new drug and a medical condition of the patient, a contraindication warning is provided.
  • Figure 16 depicts an exemplary "drug interaction" warning window for an interaction between lanoxin and eythromycin
  • Figure 17 depicts an exemplary contraindication warning window for an interaction between vancomycin and pneumonia.
  • a small box on the display screen 110 for "drug interactions" goes from green to red if a drug causing a "drug interaction" warning is selected. If a drug causing a contraindication warning is selected, a small box for contraindications goes from green to red. Either box returns to green if the respective drug is deselected.
  • a warning window includes a representation of a traffic light which blinks red. From step 196, control proceeds to step 198 or to step 200. In step 198, the sub-module 150 recommends alternative drugs to the currently selected drug. From step 198, control proceeds to step 200. In step 200, the doctor or pharmacist acknowledges the warning provided.
  • step 202 the sub-module 150 requests an indication as to whether the warning should be overrided. If the doctor or pharmacist overrides the warning, control proceeds to step 204 where the drug is selected. If the doctor or pharmacist does not override the warning, then control proceeds to step 206 where an alternative drug may be entered. From step 204 and 206, control proceeds to step 208 where drug interaction analysis by the sub-module 150 is completed.
  • step 178 the drug management process determines if the selected drug is a doser drug.
  • Figure 22 depicts an exemplary doser drug detection window for requesting an indication from the doctor or pharmacist as to whether a doser calculation is desired.
  • a doser drug is any drug having a narrow therapeutic index. If the selected drug is not a doser drug, control returns through connector B ( Figures 7A-7B). If the drug selected is a doser drug and the user elects to dose the particular drug with the doser, control proceeds to step 180 where the KINETIC_DRUG_DOSER module 126 ("doser”) is called.
  • the KINETIC_DRUG_DOSER module 126 begins at step 212 where the height and weight of the patient is confirmed.
  • step 214 it is determined whether a creatinine clearance for the patient is known.
  • a creatinine clearance represents the fluid in a patient's blood created by muscle mass.
  • the creatinine clearance is used to calculate the rate of absorption, rate of distribution, rate of metabolism, and rate of excretion of a drug in relation to the patient. If the creatinine clearance for the patient is known, then control proceeds to step 220 where the creatinine clearance is entered. If the creatinine clearance for the patient is not known, then control proceeds to step 216 where particular values are entered for calculating the creatinine clearance for the patient.
  • step 2108 the creatinine clearance is calculated. From step 220 and step 218, control proceeds to step 222 where the user indicates whether the patient is neonatal, pediatric, or adult. From step 222, control proceeds to step 224 where a volume of distribution and infusion time of the patient is entered. The volume of distribution is a number representing the area in the patient where the drug will be distributed to treat the medical condition.
  • step 226 the modifying factors of the patient are entered as depicted by the exemplary modifying factors window of Figure 23 for the drug gentamicin.
  • Modifying factors represent conditions of the patient which impact the doser calculation.
  • the modifying factors for the drug gentamicin include dehydration, overhydration, severe burns, ascities, and malnutrition.
  • the module 126 also may provide a dosing guideline specific to the selected modifying factor as illustrated by the exemplary malnutrition window of Figure 24.
  • step 230 a patient kinetic constant, half-life, and loading dose are generated.
  • kinetic constant is a fixed number used for pharmacokinetic calculations that is specific to a patient.
  • a half-life is the amount of time in hours for which a drug will last in a patient.
  • Figure 25 shows an exemplary calculated volume of distribution window.
  • step 230 control proceeds to step 232 where an estimated dosage is calculated.
  • An exemplary estimated dosage window for the drug gentamicin is shown in Figure 27.
  • step 232 control proceeds to step 236 or step 234.
  • the doctor or pharmacist has the option of entering either a peak and trough in step 236 or the option of entering a maintenance dose and an interval in step 234 as illustrated by the exemplary selected doser calculation window of Figure 28.
  • step 236 If a peak and trough are entered in step 236, control then proceeds to step 238 where a maintenance dose and interval are generated by module 126. If a maintenance dose and interval are entered in step 234, then control proceeds to step 240 where a peak and trough are calculated by the module 126. Either input process may be repeated continuously until a satisfactory set of values are achieved.
  • step 242 it is determined whether the generated and entered data is to be saved. If the doctor or pharmacist indicates that the data is not to be saved, then control returns to either step 236 or step 234. If the doctor or pharmacist elects to save the data, then control proceeds to step 244 where the doser results are displayed as illustrated by the exemplary doser results window of Figure 29. That window provides the patient ID, the drug being dosed, the total loading dose, the maintenance dose, the maintenance dose, the computed peak, computed trough, and computed average. From step 244, the drug dosing process terminates in step 246.
  • step 324 representing entry into an improved dosing stage of the dosing process (Fig. 9D). From step 324 control proceeds to step 326 where the patient height and weight are confirmed. Control next proceeds to step 328 where it is determined if the creatinine clearance for the patient is known. If the creatinine clearance is not known, then control proceeds to step 330 where values
  • step 332 the creatinine clearance is calculated. If the creatinine clearance for the patient is known, then control proceeds to step 334 where the creatinine clearance is entered. From step 332 and step 334, control proceeds to step 336 where it is determined if the patient is neonatal, pediatric or adult. From step 336 control proceeds to step 338 where it is determined if the doctor or pharmacist desires to change the maintenance dose for the patient. If the doctor or pharmacist indicates that a change is desirable, then control proceeds to step 340 where a new maintenance dose is entered. From step 340 and from step 338, if a change of the maintenance dose is not selected, control proceeds to step 342. In this step, a doctor or pharmacist is able to enter values and times for a peak blood draw and trough blood draw, an infusion length, and a time of infusion as illustrated by the exemplary improved dose calculation window of Figure 34.
  • Control then proceeds to step 344 where the volume of distribution is generated from the values provided in step 342. From step 344, control may proceed to either step 346 or step 350.
  • step 346 a desired peak and trough may be entered, and in step 350, a desired dose and interval may be entered.
  • control proceeds to step 348 where a new dose and interval are generated.
  • step 350 control proceeds to step 356 where a new dose and interval are generated.
  • Steps 346, 348, 350, and 356 are represented by the exemplary improved dose calculation window depicted in Figure 35.
  • step 358 it is determined if the doctor or pharmacist desires to save the data.
  • the doctor or pharmacist also has the options from steps 348 and 356 to repeat the process of entering the desired parameters in steps 346 or 350. If the doctor or pharmacist indicates that the data is not to be saved, then control proceeds again to either step 346 or step 350.
  • step 360 a serum drug concentration (SDC) plot may be viewed or to step 362 where the improved dosing process is completed.
  • a serum drug concentration represents a level of drug that will remain constant through doses of a drug for a patient.
  • the SDC plot represents the calculated SDC, the actual SDC, and the therapeutic range peak and trough as illustrated by the exemplary SDC plot window of Figure 36. From step 360, control terminates through step 362.
  • an ARCHINE_DATABASE_SYSTEM module 248 may be called in step 170.
  • the ARCHIVE_DATABASE_S YSTEM module 248 accesses a relational database 122 for matching a current patient's medical condition
  • step 250 the specific patient data of interest is entered as search criteria.
  • step 252 the database 122 is searched for matches with this search criteria. In this way, a clinical professional can locate previous patient therapies that have been administered for treatment of medical conditions similar to a current patient.
  • step 254 matches from the database 122 are returned along with the associated data.
  • an exemplary record 257 is shown including an upper portion which is preferably searchable and a lower portion 274 associated with the upper portion 258.
  • the upper portion 258 includes a field 262 for storing an age of a patient, a field 264 for storing the race of a patient, a field 266 for storing a sex of a patient, a field 268 for storing the infection of a patient, a field
  • the lower portion 274 includes a field 276 for storing bacteriological reports of a patient, a field 278 for storing clinical reports of a patient, and a field 280 for storing urine sample reports for a patient.
  • the process of matching patient data with the records contained in the database is completed through step 256.
  • a note feature 300 permits a doctor or pharmacist to maintain a record of events, such as consultations and non-medical intervention, for a particular patient as illustrated by the exemplary note window of Figure 32.
  • patient events may be typed directly into a note window or may be entered into the note window using a pen and a writing tablet (not shown) connected to the computer system 100.
  • a help file feature 302 provides information to a doctor or pharmacist concerning a particular drug or medical condition. In this way, a doctor or pharmacist need not leave the display section
  • a patient feature 304 allows for entry and editing of patient data.
  • a formulary feature 306 provides a list of available drugs readily accessible to the doctor or pharmacist.
  • An infusion calculator 308 for calculating infusion rates is also provided by the module 128 as illustrated by the exemplary infusion calculator windows of Figures 30-31.
  • a patient matching feature 310 renders the patient matching database 122 described above readily available upon command.
  • An Rx worksheet feature 312 provides a list of the drugs for the particular patient along with a start date, end date, date the order is written, date inventory is verified, and the date the order is filled for each drug as illustrated by the exemplary Rx
  • An advisories feature 314 provides a doctor or pharmacist with some advisories that are specific to a particular drug and other advisories that are specific to the class of patient (neonatal, pediatric, and geriatric).
  • Figure 21 depicts an exemplary advisory window for the drug vancomycn.
  • a doser function 316 provides for the KINETIC_DRUG_DOSER module as described above.
  • a contradictions feature 318 and a drug interactions feature 322 permit a doctor or pharmacist at any time to check the current list of contradictions and "drug interactions.” For example, a list of contradictions is depicted by the exemplary contradictions list window of Figure 18.
  • a diagnosis feature 320 provides for reviewing and adding medical conditions for a particular patient.
  • a doctor or pharmacist knows about drug interaction problems before writing an order, eliminating the problem of locating a doctor when a drug interaction problem is discovered for an order already written by the doctor.
  • the pharmacy drug management software of the present invention also permits doctors and pharmacists to view advisories, drug and medical condition information help files, patient data, and orders so that a doctor or pharmacist need not leave the screen of the computer system 100 to properly diagnose patients.
  • the present invention automatically detects whether a drug is a doser drug needing precise therapeutic dosing and automatically checks for drug interaction problems based on the patient data, reducing the likelihood of clinical misjudgments and clinical liability for adverse drug reactions.
  • the present invention thus overall provides a total drug care system.

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Abstract

Un système de gestion de médicaments de pharmacie présente un logiciel de gestion des médicaments de pharmacie pour la posologie des médicaments spécifique à des patients, l'analyse d'interactions médicamenteuses, la génération de prescriptions et une adaptation des données de patients. Lorsqu'un médicament est ajouté pour un patient, le système détecte si le médicament est un médicament à doseur requérant une posologie thérapeutique précise et il détecte également si le médicament peut engendrer d'éventuels problèmes d'interactions médicamenteuses pour le patient, réduisant la probabilité d'erreurs de jugement clinique. Le système procède à une vérification des problèmes d'interactions médicamenteuses ayant pour cause des médicaments, des allergies alimentaires ainsi que l'état médical du patient. Une prescription sur écran peut alors être produite. Un docteur ou un pharmacien est ainsi informé des éventuels problèmes d'interactions médicamenteuses avant de rédiger la prescription d'un patient. Si un médicament sélectionné est un médicament à doseur, le système utilise des équations pharmacocinétiques spécifiques aux données du patient afin de calculer les paramètres de posologie thérapeutique appropriés. Par un module de gestion de thérapie du logiciel de gestion de médicaments de pharmacie, un professionnel clinicien peut accéder à un formulaire établissant la liste des médicaments disponibles, à des avis concernant des médicaments, des fichiers d'aide d'information sur les médicaments et les états médicaux, un calculateur de perfusion, une note destinée à enregistrer les événements concernant le patient, il peut accéder à une base de données d'adaptation des données du patient afin de localiser les thérapies pour des patients présentant des états médicaux similaires à ceux du patient particulier, ainsi qu'à d'autres outils de thérapie, tous à partir de l'écran d'un système informatique exploitant le logiciel.
PCT/US1999/003008 1998-02-27 1999-02-12 Systeme de gestion de medicaments de pharmacie procurant une posologie de medicaments specifique au patient, une analyse des interactions medicamenteuses, la generation de prescriptions et une adaptation des donnees du patient WO1999044167A1 (fr)

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